MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE TAPERED IMPLANT 5 X 10MM; DENTAL MOUNT

Catalog Number	NT510
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported that after placing implant with final ratchet at tooth site 36 implant could not disengage from mount.Doctor was not able to disengage it, not even in reverse.Doctor had to remove the implant and placed another one.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Zimvie received one (1) nt510, nanotite¿ tapered certain® implant 5 x 8.5 - 15mm for evaluation.Visual and functional evaluation were performed.The returned implant and mount have signs of use.During a functional test the implant did not disengage from the mount.Dhr review was completed for the subject lot number 2023060007.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2023060007 for similar events and no other complaint was identified.Review completed utilizing keywords: dental : functional : does not disengage/release.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was possibly user caused/excessive torque applied.Therefore, based on the available information, a device malfunction did occur.The mount is stuck to the implant.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: OSSEOTITE TAPERED IMPLANT 5 X 10MM
• Common Device Name: DENTAL MOUNT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 19061861
• Report Number: 0001038806-2024-00693
• Device Sequence Number: 5870569
• Product Code: DZE
• UDI-Device Identifier: 00844868012061
• UDI-Public: (01)00844868012061(17)280626(10)2023060007
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K063286
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: NT510
• Device Lot Number: 2023060007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic